Chief Operating Officer

PARACRINE THERAPEUTICS PTE. LTD.; Singapore; On-site; SGD 180,000 - 360,000; Full time

Job summary

PARACRINE THERAPEUTICS PTE. LTD.

in Singapore is seeking a senior leader to translate corporate strategy into actionable plans, work with the CEO and board on strategic initiatives, and oversee the annual operating plan, budget and resource allocation to drive growth. You will supervise end-to-end operations across R&D, manufacturing, quality, regulatory and clinical development, shape partnerships, and ensure efficient use of funds, staff and facilities to deliver on product development and

Job description

Key Responsibilities

1. Corporate Strategy and Business Operations

• Translate the company's corporate strategy and business objectives into actionable operational plans, milestones and performance targets.
• Work closely with the CEO and Board of Directors on strategic initiatives, business planning, corporate development and organisational growth.
• Support fundraising activities, investor presentations, strategic partnerships and due diligence processes.
• Lead the development and implementation of the company's annual operating plan, budget and resource allocation.
• Oversee day-to-day business operations to ensure organisational efficiency, accountability and alignment with strategic priorities.
• Establish appropriate organisational structures, operating procedures, governance frameworks and management reporting systems.
• Identify operational risks, bottlenecks and opportunities for process improvement.

2. Research and Development Operations

• Oversee the operational management of R&D programmes
• Ensure effective coordination between scientific research, process development, analytical development and research team.
• Establish project management frameworks to monitor R&D milestones, timelines, budgets and deliverables.
• Support the development of intellectual property, technology platforms and product pipeline in collaboration with the scientific leadership team.
• Ensure that R&D activities are aligned with the company's product development strategy and regulatory requirements.

3. Manufacturing and Process Development

• Lead the development and implementation of manufacturing strategies
• Oversee process development, scale-up, technology transfer and manufacturing readiness.
• Drive the establishment of robust and reproducible manufacturing processes, including upstream and downstream production.
• Ensure appropriate controls over raw materials, starting materials, production processes and critical quality attributes.
• Evaluate opportunities for contract development and manufacturing organisation (CDMO) partnerships and strategic outsourcing.

4. Quality Management and Regulatory Compliance

• Establish and maintain an effective Quality Management System (QMS) appropriate to the company's stage of development and intended product applications.
• Ensure compliance with applicable regulatory requirements, including relevant Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and other applicable quality standards.
• Oversee quality assurance, quality control, documentation, deviation management, corrective and preventive action, change control and risk management.
• Work closely with regulatory consultants and relevant authorities to develop regulatory strategies.
• Support the preparation of regulatory submissions, product dossiers, manufacturing documentation and clinical trial applications.
• Ensure appropriate product characterisation, identity, purity, potency, safety and consistency strategies are established.
• Maintain a culture of quality, regulatory compliance and continuous improvement throughout the organisation.

5. Clinical Development and Product Commercialisation

• Work with scientific, clinical and regulatory teams to develop product development and clinical translation strategies.
• Oversee operational planning and coordination for preclinical studies, clinical development programmes and external research collaborations.
• Support the development of product pipelines, target indications and commercialisation roadmaps.
• Identify opportunities for strategic collaborations with hospitals, universities, research institutions, clinical investigators and biotechnology partners.
• Develop operational capabilities to support future product registration, market entry and commercial manufacturing.
• Ensure that product development and commercialisation activities are aligned with applicable regulatory and evidence requirements.

6. Business Development and Strategic Partnerships

• Identify and evaluate strategic business opportunities, partnerships, licensing arrangements and technology collaborations.
• Develop relationships with biotechnology companies, pharmaceutical organisations, healthcare institutions, investors and research organisations.
• Support commercial negotiations, partnership agreements, technology licensing and joint development initiatives.
• Evaluate new business opportunities based on technical feasibility, commercial potential, regulatory considerations and financial viability.
• Support the CEO in developing the company's market positioning, growth strategy and long-term business development plans.

7. Financial and Resource Management

• Oversee operational budgeting, financial planning and cost management in collaboration with the finance function.
• Monitor operating expenditure, capital expenditure, cash flow requirements and departmental budgets.
• Ensure effective allocation of financial, human and technical resources.
• Establish key performance